SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot (NCT04907214), a na phase 1, phase 2 study. The primary outcome is Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months.

2. Clinical Question

3. Trial Design

The registry record identifies this as a completed Phase 1 and Phase 2 study with an enrollment of 29. Its recorded model is single group, allocation is NA, and masking is none. The listed intervention is empagliflozin 25 MG, described as oral empagliflozin 25mg/day for 12 weeks. The record lists no comparator arm, so the design information does not describe a randomized treatment-versus-control contrast.

The brief study description refers to a randomized controlled trial, but that wording does not match the recorded design fields. The record’s explicit design information lists a single-group model and no allocation; its accompanying note also says the arms are not a like-for-like control comparison. The design should therefore be read from those recorded details, not as evidence of a randomized comparison. No separate explanation of this inconsistency is reported in the registry record.

The primary endpoint is a change in adipose pro-inflammatory T helper type 1 cell percentages from baseline to 12 weeks. The record also lists secondary outcomes for change in those cell percentages after 2 weeks and change in plasma inflammatory cytokine IL-6 after 3 months. It states that there are five outcome measures, but the individual results for these outcomes are not reported in the available record information.

The study is marked completed. Its listed start date is 2021-07-29 and its primary completion date is 2023-12-08. The registry record does not report a control group, an allocation procedure, or masking beyond the values noted above. It also does not report a detailed protocol or a sample-size justification.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: * 17 in the Original study + 21 in the Extension study signed consent for a total of 38. * 9 individuals in the Extension study did not perform screening procedures after consent and were not enrolled. In total 29 individuals enrolled. * 11 individuals in the Original study and 2 individuals in the Extension study did not meet inclusion/exclusion criteria after screening. * 6 individuals in the Original study and 10 individuals in the Extension study started and completed study days.

Overall Study

Analysis population for the primary outcome, as defined in the registry: One individual did not tolerate the liposuction technique and did not provide adipose tissue for the study.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months, measured over Baseline to 12 weeks.

The primary endpoint is the change from baseline to 12 weeks in the percentage of adipose pro-inflammatory T helper type 1 cells, expressed as a percentage of CD3+ T cells. The registry record says the cells are quantified using flow cytometry. It also notes that one individual did not tolerate the liposuction technique and did not provide adipose tissue for the study.

As a measure, this endpoint focuses on a cellular feature of adipose tissue rather than a clinical event. General explanation: a percentage describes the share of a specified cell population represented by the cell type of interest. A change over time can be used to describe whether that share differs between a baseline measurement and a later measurement. Such a measure is a surrogate or biological outcome; it is not, by itself, a measure of cardiovascular events or proof that a biological change causes a clinical benefit.

The study description frames adipose inflammation as relevant to its research question. However, the numerical baseline and follow-up values, the estimated change, its standard deviation, and any confidence interval or test result are not reported in the registry record. The endpoint’s observed direction and precision therefore cannot be assessed from the information available.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record lists the primary measure as a mean for a continuous outcome, with standard deviation as the dispersion measure. It does not report the actual mean, standard deviation, or endpoint analysis result. The following concepts explain how such statistics are generally interpreted; they do not fill in results missing from the record.

What does a mean change describe?

General explanation: for a continuous measure, a mean change summarizes the average difference between measurements at two time points across the participants included in an analysis. It provides a central summary, but does not show how much individuals varied. The registry names a baseline-to-12-week comparison for the primary endpoint. The numerical mean change is not reported in the registry record, so its size and direction cannot be stated.

The endpoint is a cell percentage. Interpreting a change in a percentage requires knowing the values at the relevant time points and how the change was defined and analyzed. Those details beyond the stated timeframe and measurement are not reported in the registry record. No recalculated estimate can be described without the posted summary statistics.

What does a standard deviation describe?

General explanation: a standard deviation describes the spread of individual measurements around their mean. It is not the same as a confidence interval. A larger spread indicates more variation among the observed measurements, while the standard deviation alone does not tell how precisely the mean has been estimated. The registry identifies standard deviation as the endpoint’s dispersion measure, but does not report its numerical value.

How would a confidence interval help?

General explanation: a confidence interval expresses statistical uncertainty around an estimate under the assumptions of the method used to construct it. The interval can help readers assess which values are compatible with the observed data and analysis. It does not eliminate design limitations or show that a result is clinically important. No confidence interval for the primary endpoint is reported in the registry record.

What does the design allow?

The listed design is single group, with allocation NA and masking none. General explanation: repeated measurements in one group can describe change over time, but a before-and-after difference does not provide the same evidence as a randomized comparison with a concurrent control group. In particular, it cannot by itself distinguish an intervention-associated change from other time-related or measurement-related explanations. The registry’s brief summary uses the phrase randomized controlled trial, but the recorded model and allocation information do not describe a randomized comparator.

The record does not report whether the primary analysis used a paired method, a model-based method, or another approach. It does not report adjustments, assumptions checks, or a statistical analysis plan. Those details should not be inferred from the endpoint’s mean-and-standard-deviation description.

What does the planning illustration mean?

The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. General explanation: a planning calculation estimates the sample size needed under specified assumptions for a future comparison. It is not a result observed in the current study, and it is not observed power. The illustrations do not describe the enrolled study’s single-group design. No numeric planning estimates or observed-effect value are reported in the registry record.

The record’s note distinguishes participants per arm for 80% power from the total number of events used in time-to-event planning. The primary endpoint is continuous, and the numeric planning values are not reported. No actual sample-size justification for this study is reported in the registry record, so the illustration should not be interpreted as the trial’s original enrollment target rationale.

Why can over-dispersion matter?

General explanation: over-dispersion describes variability greater than a statistical model expects. When a model assumes less variability than is present, its uncertainty estimates can be too small and its tests can appear more precise than warranted. This is a general statistical consideration, not a reported finding for this trial. The registry record does not report a model-based analysis or a check for over-dispersion.

Because the numerical primary outcome and its analysis are not reported, there is no basis for independently checking the estimate, its standard error, its confidence interval, or its statistical test. The registry record also does not report enough summary statistics to make a simple unadjusted recalculation.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Empagliflozin")
n   <- c(5)
m   <- c(-1.6)
sp  <- c(1.8)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Empagliflozin  5  -1.600  1.800  -3.835  0.635

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary endpoint and identifies secondary outcomes, including a 2-week change in adipose pro-inflammatory T helper type 1 cell percentages and a 3-month change in plasma inflammatory cytokine IL-6. It also states that there are five outcome measures. However, the available information does not report the full outcome results or how the analyses were prioritized and interpreted.

When several outcomes or time points are examined, general statistical explanation is that the chance of a false-positive finding can increase if each is tested separately without accounting for multiplicity. A prespecified analysis plan can explain which outcome is primary, how secondary analyses are treated, and whether any adjustment is intended. The registry record does not report a multiplicity strategy, and no specific adjustment should be assumed.

Missing data are relevant to the primary endpoint: one individual did not tolerate liposuction and did not provide adipose tissue. The record does not report the number analyzed for the primary endpoint, whether any other measurements were missing, or how missing data were handled. It also does not report whether an analysis population was defined, such as an intention-to-treat or per-protocol population. These details are not reported in the registry record.

The registry lists zero analysis records in the information available. This means the endpoint’s statistical analysis, including any handling of missing observations or multiple outcomes, cannot be evaluated from the recorded information. The enrollment figure does not establish the denominator for each outcome analysis.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety figures list six participants at risk for serious adverse events, zero with a serious adverse event, and zero deaths. For other adverse events, six participants are listed at risk and two are listed as affected. No serious adverse-event terms are listed. These are the counts reported in the registry record; they should not be read as a complete description of event types or timing.

The at-risk groups are small, so the counts provide limited information about the range or frequency of possible events. General explanation: an observed count of zero in a small group does not establish that an event cannot occur. Similarly, the listing of two participants with other adverse events does not by itself describe severity, duration, relatedness to treatment, or clinical importance. Those details are not reported in the registry record.

The adverse-event denominators are not the same as the overall enrollment listed for the study. The record does not explain the difference or provide further safety-analysis details. These counts should therefore be interpreted as the specific registry figures reported, not as an estimate of safety for a wider population.

13. What the Result Does, and Does Not, Mean

The registry record establishes that a completed single-group pilot enrolled 29 people and studied empagliflozin 25mg/day orally for 12 weeks. Its primary endpoint was change from baseline to 12 weeks in adipose pro-inflammatory T helper type 1 cell percentages among CD3+ T cells, measured using flow cytometry. The record also identifies secondary inflammatory outcomes and reports adverse-event counts.

It does not report a numerical primary endpoint result or the corresponding uncertainty. Readers therefore cannot determine from this record whether the cell percentage increased, decreased, or remained similar, nor how precisely any estimated change was measured. The record also does not give results for the listed secondary outcomes.

The single-group design does not provide a concurrent control comparison. General explanation: a change observed between baseline and follow-up can be described, but it does not alone establish that the intervention caused that change. The lack of a recorded comparator also limits comparison with what might have happened over the same period without the intervention. The brief summary’s reference to a randomized controlled trial is inconsistent with the listed model and allocation details, which identify a single group and allocation as NA.

The primary outcome is a biological measure, not a clinical cardiovascular event. Even if a numerical change were reported, that cellular measure alone would not establish an effect on cardiovascular disease. The registry record does not report such clinical outcome results or a causal analysis linking adipose inflammation to cardiovascular outcomes.

The safety figures report no serious adverse events or deaths among six participants listed at risk and two participants with other adverse events among six at risk. These counts are limited observations and do not establish the absence of risk. Overall, the record describes the study question and design but does not provide enough outcome-analysis information to assess the size, precision, or cause of changes in the primary endpoint.

14. Why This Trial Matters Statistically

This trial’s statistical importance lies partly in the distinction between a biological research question and the evidence its design can provide. The primary measure captures a cell percentage in adipose tissue over time. It addresses a specific inflammatory feature, while remaining different from a clinical outcome such as a cardiovascular event. Separating those outcome types helps prevent a surrogate measure from being interpreted as direct evidence about clinical disease.

The recorded design also matters. The brief summary describes a randomized controlled trial, but the design fields identify a single group, no allocation, and no masking. A clear reading of the design is essential because a within-group change and a randomized between-group contrast answer different questions. The record does not provide a control-group comparison that can distinguish an intervention-associated change from other changes over time.

Missing tissue is another relevant statistical feature. One individual did not tolerate the liposuction technique and did not provide adipose tissue. For a tissue-based endpoint, the number and characteristics of participants with usable measurements can affect how representative an analysis is. The record does not report the analyzed population or the handling of missing tissue, so those aspects cannot be assessed.

Finally, statistical interpretation depends on estimates and uncertainty, not only on an outcome’s name or a study’s completion status. The numerical primary and secondary results are not reported in the registry record. Without those results, it is not possible to evaluate effect size, precision, or consistency across outcomes. The record therefore highlights why transparent outcome reporting and clearly described analysis populations are important to interpreting a pilot study.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this trial can be identified from the registry record. The recorded design is single group, with allocation listed as NA and masking as none. No comparator is listed, and the record itself notes that the arms are not a like-for-like control comparison. The brief summary’s description of a randomized controlled trial conflicts with those recorded design details; the registry record does not explain the discrepancy.

The primary endpoint requires adipose tissue, and one individual did not tolerate liposuction and did not provide tissue. The total number included in the endpoint analysis and the handling of that missing measurement are not reported in the registry record. No further analysis-population details are reported.

Although the study is marked completed and identifies five outcome measures, the numerical primary and secondary outcome results are not reported in the information available. The record does not report estimates, dispersion values, confidence intervals, p-values, or a statistical analysis plan. It also does not report a multiplicity approach or a sample-size justification for the study.

The study description focuses on adipose inflammation and surrogate measures of cardiovascular disease, but the listed primary endpoint is a cellular percentage. The registry record does not report clinical cardiovascular outcome results. The safety information lists six participants at risk in each adverse-event category; these counts are limited and do not provide detailed event descriptions or a broader assessment of safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot — NCT04907214.
• Registry record last updated 2023-12-29; status last verified 2023-12.
• Results first posted 2023-02-01.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed Phase 1 and Phase 2 single-group study of empagliflozin 25 MG in people with obesity and pre-diabetes. Enrollment was 29. The intervention description states oral empagliflozin 25mg/day for 12 weeks. Allocation is listed as NA and masking as none.

The primary endpoint is change from baseline to 12 weeks in adipose pro-inflammatory T helper type 1 cell percentages among CD3+ T cells, quantified using flow cytometry. One individual did not provide adipose tissue because liposuction was not tolerated. The numerical endpoint results, analysis population, and missing-data approach are not reported in the registry record.

Safety listings report zero serious adverse events, zero deaths, and two participants with other adverse events, with six at risk in each category. The record lists secondary inflammatory outcomes but does not report their numerical results.